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Pilot Study of NPL-2003 in Adults With Obsessive-Compulsive Disorder (OCD)
This study is currently recruiting participants.
Verified by New York State Psychiatric Institute, August 2008
Sponsored by: New York State Psychiatric Institute
Information provided by: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00728923
  Purpose

Obsessive-compulsive disorder (OCD) is a common psychiatric illness that affects up to 2-3% of the population. People with OCD experience anxiety-provoking, intrusive thoughts, known as obsessions, and feel compelled to perform repetitive behaviors, or compulsions. The only medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with SRI treatment, most patients continue to experience significant OCD symptoms, impaired functioning, and diminished quality of life. Recent evidence suggest that a different neurotransmitter, glutamate, may contribute to the symptoms in OCD. Medications that target glutamate hold promise for ameliorating symptoms for those patients continuing to suffer from OCD. In this study we are recruiting patients to receive the drug NPL-2003, which is thought to modulate the neurotransmitter glutamate, added to whatever other OCD medications they are taking in a 12-week open label study.


Condition Intervention Phase
Obsessive Compulsive Disorder
Drug: NPL-2003
Phase II

MedlinePlus related topics: Obsessive-Compulsive Disorder
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Pilot Study of NPL-2003 in Adults With Obsessive-Compulsive Disorder (OCD)

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Improvement in severity of symptoms as measured by YBOCS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HAM-D [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
NPL-2003
Drug: NPL-2003
NPL-2003 (5707) daily for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary Diagnosis of OCD
  • Currently on a stable and adequate dose of SRI (or history of prior SRI or CBT treatment meeting criteria for adequate trial)
  • Sufficient severity of symptoms to warrant additional augmentation treatment
  • Able to provide consent

Exclusion Criteria:

  • Medical or psychiatric conditions that would make participation unsafe
  • Female patients who are either pregnant or nursing
  • Documented history of hypersensitivity or intolerance to drugs in class of NPL-2003
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728923

Contacts
Contact: Carolyn I. Rodriguez, M.D., Ph.D. 212-543-5637

Locations
United States, New York
New York State Psychiatric Institute Recruiting
Bronx, New York, United States, 10032
Contact: Carolyn I. Rodriguez, M.D., Ph.D.     212-543-5637        
Principal Investigator: Carolyn I. Rodriguez, M.D., Ph.D.            
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Carolyn I. Rodriguez, M.D., Ph.D. Columbia-NYSPI-RFMH
  More Information

Columbia University Obsessive-Compulsive Disorder Research Clinic  This link exits the ClinicalTrials.gov site

Responsible Party: Columbia-NYSPI-RFMH ( Carolyn Rodriguez, M.D., Ph.D. )
Study ID Numbers: 5707
Study First Received: July 31, 2008
Last Updated: August 6, 2008
ClinicalTrials.gov Identifier: NCT00728923  
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
OCD

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders
Obsessive-Compulsive Disorder

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 13, 2009